洛铂联合紫杉醇与卡铂联合紫杉醇一线治疗局部晚期或转移性非小细胞肺癌有效性和安全性旳随机、对照、多中心Ⅲ期临床研究

摘要

目的 观察和比较TL方案(洛铂联合紫杉醇)与TC方案(卡铂联合紫杉醇)一线治疗晚期非小细胞肺癌(NSCLC)的有效性和安全性.方法 设计前瞻性、随机、对照的全国多中心Ⅲ期临床研究,纳入初治的ⅢB/IV期NSCLC受试者,随机分为TL组和TC组.TL组:紫杉醇(PTX) 175 mg/m2,静脉滴注,d1 ;洛铂(LBP) 30 mg/m2,静脉滴注,d2.TC组:PTX,同前;卡铂(CBP):AUC = 5,静脉滴注,d2;均为21天为1周期,最多治疗6周期.主要研究终点为无进展生存期(PFS),次要研究终点包括总生存期(OS)、客观有效率(ORR)、疾病控制率(DCR)、安全性及生活质量.结果 13家研究中心共入组359例受试者,其中TL组181例,TC组178例.TL组和TC组的中位PFS分别为5.37个月vs.5.17个月(HR = 0.874,95％CI:0.678-1.126;P=0.2962),中位 OS分别为12.90个月 vs.12.17个月(HR = 0.967,95％CI:0.774-1.208;P=0.7666);两组的ORR分别为35.47％ vs.38.64％(P=0.5795) ,DCR分别为80.23％ 80.11％(P= 1.0000) .安全性方面,TL和 TC组的不良事件(AE)总的发生率分别为95.51％ vs.99.44％(P=0.0463),3/4级AE发生率分别为66.29％ vs.80.90％(P=0.0018) .生活质量方面,TL组的部分指标优于TC组.结论 TL方案一线治疗晚期NSCLC与标准的TC方案疗效相近,但是TL方案在安全性和生活质量方面优于TC方案.因此,含LBP的TL方案可以作为国人晚期NSCLC-线治疗的新选择,值得在临床上积极推广应用.%Objective To compare the efficacy and safety of lobaplatin (LBP) plus paclitaxel (TL regimen) versus carboplatin (CBP) plus paclitaxel (TC regimen) as the first-line therapy in Chinese advanced non-small cell lung cancer (NSCLC). Methods A prospective, randoimzed, controlled national multicenter phase Ⅲ clinical study was designed. NSCLC treatment-naive patients with stage ⅢB/Ⅳ were included in this study, randomly divided into TL group and TC group. TL group: paclitaxel (175 mg/m2 by intravenous infusion on day 1) and LBP (30 mg/m2 by intravenous infusion on day 2), 21 days as a cycle for 6 cycles. TC group: paclitaxel (175 mg/m2 by intravenous infusion on day 1) and CBP(AUC = 5 on day 2), 21 days as a cycle for 6 cycles. The primary endpoint was progression free survival (PFS). The secondary endpoints included overall survival(OS), obje ctive response rate (ORR), disease control rate (DCR) and quality of life (QoL). Resutlts A total of three hundred and fifty-nine patients were enrolled from 13 centers in China, including 181 patients in TL group and 178 patients in TC group. The median PFS in TL and TC group was 5.37 vs.5.17 months (HR = 0.874, 95％ CI: 0.678-1.126;P = 0.2962) respectively, the median OS was 12.90 vs.12.17 months(HR = 0.967, 95％ CI: 0.774-1.208; P=0.7666). ORR and DCR in TL and TC group were 35.47％ vs.38.64％(P = 0.5795) and 80.23％ vs.80.11 ％ (P = 1.0000), respectively. In terms of safety, the overall incidence of AE and grade 3/4 AEs in TL and TC group were 95.51％ vs.99.44％ (P = 0.0463) and 66.29％ vs.80.90％ (P = 0.0018), respectively. Some indicators of TL group were better than those of TC group in quality of life. Conclusion The efficacy of TL regimen was almost same with TC regimen, but safety and quality of life of TL regimen were better than those of TC regimen. Thus TL regimen containing LBP may offer an alternative first-line therapy regimen for Chinese advanced NSCLC patients, and it is worth to be widely applied in clinical practice further.